Fungizone

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pale skin, easy bruising;
• blood in your stools;
• a light-headed feeling, like you might pass out;
• seizure (convulsions);
• jaundice (yellowing of the skin or eyes);
• build-up of fluid in your lungs--anxiety, sweating, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate;
• signs of a kidney problem--little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
• signs of new infection--fever, chills, flu symptoms, mouth and throat ulcers, rapid and shallow breathing.

Common side effects may include:

• nausea, vomiting, stomach pain, diarrhea;
• upset stomach, loss of appetite;
• muscle or joint pain;
• headache, ringing in your ears;
• pain, bruising, or swelling where the medicine was injected;
• weight loss; or
• flushing (warmth, redness, or tingly feeling).

Amphotericin B is injected into a vein through an IV. A healthcare provider will give you this injection.

The medicine must be given slowly through an IV infusion, and can take from 2 to 6 hours to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when amphotericin B is injected.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

While receiving amphotericin B, you may need frequent blood tests.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Amphotericin B will not treat a viral infection such as the common cold or flu.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphotericin B can be fatal.

Call your doctor for instructions if you miss an appointment for your amphotericin B injection.

Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest (see WARNINGS and DOSAGE AND ADMINISTRATION). If an overdose is suspected, discontinue therapy and monitor the patient's clinical status (e.g., cardiorespiratory, renal, and liver function, hematologic status, serum electrolytes) and administer supportive therapy, as required. Amphotericin B is not hemodialyzable.

Prior to reinstituting therapy, the patient's condition should be stabilized (including correction of electrolyte deficiencies, etc.).

Although some patients may tolerate full intravenous doses of amphotericin B without difficulty, most will exhibit some intolerance, often at less than the full therapeutic dose.

Tolerance may be improved by treatment with aspirin, antipyretics (e.g., acetaminophen), antihistamines, or antiemetics. Meperidine (25 to 50 mg IV) has been shown in some patients to decrease the duration of shaking chills and fever that may accompany the infusion of amphotericin B.

Administration of amphotericin B on alternate days may decrease anorexia and phlebitis.

Intravenous administration of small doses of adrenal corticosteroids just prior to or during the amphotericin B infusion may help decrease febrile reactions. Dosage and duration of such corticosteroid therapy should be kept to a minimum (see PRECAUTIONS: DRUG INTERACTIONS).

Addition of heparin (1000 units per infusion), and the use of pediatric scalp-vein needle may lessen the incidence of thrombophlebitis.

Extravasation may cause chemical irritation.

The adverse reactions most commonly observed are:

General (body as a whole): fever (sometimes accompanied by shaking chills usually occurring within 15 to 20 minutes after initiation of treatment); malaise; weight loss.

Cardiopulmonary: hypotension; tachypnea.

Gastrointestinal: anorexia; nausea; vomiting; diarrhea; dyspepsia; cramping epigastric pain.

Hematologic: normochromic, normocytic anemia.

Local: pain at the injection site with or without phlebitis or thrombophlebitis.

Musculoskeletal: generalized pain, including muscle and joint pains.

Neurologic:headache.

Renal: decreased renal function and renal function abnormalities including: azotemia, hypokalemia, hyposthenuria, renal tubular acidosis; and nephrocalcinosis. These usually improve with interruption of therapy. However, some permanent impairment often occurs, especially in those patients receiving large amounts (over 5 g) of amphotericin B or receiving other nephrotoxic agents. In some patients hydration and sodium repletion prior to amphotericin B administration may reduce the risk of developing nephrotoxicity. Supplemental alkali medication may decrease renal tubular acidosis.

The following adverse reactions have also been reported:

General (body as a whole): flushing.

Allergic: anaphylactoid and other allergic reactions; bronchospasm; wheezing.

Cardiopulmonary: cardiac arrest; shock; cardiac failure; pulmonary edema; hypersensitivity pneumonitis; arrhythmias, including ventricular fibrillation; dyspnea; hypertension.

Dermatologic: rash, in particular maculopapular; pruritus. Skin exfoliation, toxic epidermal necrolysis, and Stevens-Johnson syndrome have been reported during post-marketing surveillance.

Gastrointestinal:acute liver failure; hepatitis; jaundice; hemorrhagic gastroenteritis; melena.

Hematologic: agranulocytosis; coagulation defects; thrombocytopenia; leukopenia; eosinophilia; leukocytosis.

Neurologic: convulsions; hearing loss; tinnitus; transient vertigo; visual impairment; diplopia; peripheral neuropathy; encephalopathy (see PRECAUTIONS); other neurologic symptoms.

Renal: acute renal failure; anuria; oliguria. Nephrogenic diabetes insipidus has been reported during post-marketing surveillance.

Serum Electrolytes: Hypomagnesemia; hypo- and hyperkalemia; hypocalcemia.

Liver Function Tests: Elevations of AST, ALT, GGT, bilirubin, and alkaline phosphatase.

Renal Function Tests: Elevations of BUN and serum creatinine.

Read the entire FDA prescribing information for Fungizone (Amphotericin B)

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© Fungizone Patient Information is supplied by Cerner Multum, Inc. and Fungizone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Amphotericin B is an antifungal medication that fights infections caused by fungus.

Amphotericin B is used to treat serious, life-threatening fungal infections. It is not for use in treating a minor fungal infection such as a yeast infection of the mouth, esophagus, or vagina.

Amphotericin B may also be used for purposes not listed in this medication guide.

Amphotericin B is injected into a vein through an IV. A healthcare provider will give you this injection.

The medicine must be given slowly through an IV infusion, and can take from 2 to 6 hours to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when amphotericin B is injected.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

While receiving amphotericin B, you may need frequent blood tests.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Amphotericin B will not treat a viral infection such as the common cold or flu.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pale skin, easy bruising;

• blood in your stools;

• a light-headed feeling, like you might pass out;

• seizure (convulsions);

• jaundice (yellowing of the skin or eyes);

• build-up of fluid in your lungs--anxiety, sweating, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate;

• signs of a kidney problem--little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;

• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

• signs of new infection--fever, chills, flu symptoms, mouth and throat ulcers, rapid and shallow breathing.

Common side effects may include:

• nausea, vomiting, stomach pain, diarrhea;

• upset stomach, loss of appetite;

• muscle or joint pain;

• headache, ringing in your ears;

• pain, bruising, or swelling where the medicine was injected;

• weight loss; or

• flushing (warmth, redness, or tingly feeling).

Microbiology

Amphotericin B shows a high order of in vitro activity against many species of fungi. Histoplasma capsulatum, Coccidioides immitis, Candida species, Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenckii, Mucor mucedo, and Aspergillus fumigatus are all inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/mL in vitro. While Candida albicans is generally quite susceptible to amphotericin B, non-albicans species may be less susceptible. Pseudallescheria boydii and Fusarium sp. are often resistant to amphotericin B. The antibiotic is without effect on bacteria, rickettsiae, and viruses.

Standardized techniques for susceptibility testing for antifungal agents have not been established and results of susceptibility studies have not been correlated with clinical outcomes.

Pharmacokinetics

Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols in the cell membrane of susceptible fungi with a resultant change in membrane permeability allowing leakage of intracellular components. Mammalian cell membranes also contain sterols and it has been suggested that the damage to human cells and fungal cells may share common mechanisms.

An initial intravenous infusion of 1 to 5 mg of amphotericin B per day, gradually increased to 0.4 to 0.6 mg/kg daily, produces peak plasma concentrations ranging from approximately 0.5 to 2 mcg/mL. Following a rapid initial fall, plasma concentrations plateau at about 0.5 mcg/mL. An elimination half-life of approximately 15 days follows an initial plasma half-life of about 24 hours. Amphotericin B circulating in plasma is highly bound (>90%) to plasma proteins and is poorly dialyzable. Approximately two thirds of concurrent plasma concentrations have been detected in fluids from inflamed pleura, peritoneum, synovium, and aqueous humor. Concentrations in the cerebrospinal fluid seldom exceed 2.5% of those in the plasma. Little amphotericin B penetrates into vitreous humor or normal amniotic fluid. Complete details of tissue distribution are not known.

Amphotericin B is excreted very slowly (over weeks to months) by the kidneys with 2 to 5% of a given dose being excreted in the biologically active form. Details of possible metabolic pathways are not known. After treatment is discontinued, the drug can be detected in the urine for at least 7 weeks due to the slow disappearance of the drug. The cumulative urinary output over a 7-day period amounts to approximately 40% of the amount of drug infused.

Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest (see WARNINGS and DOSAGE AND ADMINISTRATION). If an overdose is suspected, discontinue therapy and monitor the patient’s clinical status (e.g., cardiorespiratory, renal, and liver function, hematologic status, serum electrolytes) and administer supportive therapy, as required. Amphotericin B is not hemodialyzable.

Prior to reinstituting therapy, the patient’s condition should be stabilized (including correction of electrolyte deficiencies, etc.).